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NCT04903470 · ClinicalTrials.gov registry record · NA

Defecation Patterns in Constipated Patients

A NA study of Constipation by Outlet Obstruction, sponsored by The California Medical Innovations Institute.

Recruiting
Registry status
NA
Development phase
130
Enrollment target
2
Study locations

NCT04903470: Recruiting NA study of Constipation by Outlet Obstruction, sponsored by The California Medical Innovations Institute.

NCT04903470 is a NA study of Constipation by Outlet Obstruction that is actively recruiting participants, run by The California Medical Innovations Institute. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04903470, a NA study of Constipation by Outlet Obstruction, is actively recruiting participants, sponsored by The California Medical Innovations Institute.

RECRUITING
Registry status
NA
Development phase
130 participants
Enrollment target
2
Study locations

Study Summary

Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deforma

Primary Outcome

Evacuation duration is the time it takes from evacuation is initiated until the balloon is expelled. Change from the evacuation duration baseline induced by atropine and bisacodyl.

Interventions

  • DRUG Bisacodyl
  • DRUG Atropin

Study Locations (2)

California

  • California Medical Innovations Institute - San Diego

Georgia

  • Augusta University Medical Center - Augusta

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2022-12-19
Est. Completion 2026-12-30
Phase NA

What NCT04903470 shows while recruiting

NCT04903470 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Constipation by Outlet Obstruction appearing as the primary indexed condition, and to 2 interventions - of which Bisacodyl is the first listed.

NCT04903470 reports a single indexed study location in California, Georgia.

Frequently Asked Questions

What is clinical trial NCT04903470 about?

NCT04903470 is a clinical study titled "Defecation Patterns in Constipated Patients". Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide inc...

What is the current status of trial NCT04903470?

This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2022-12-19. Estimated completion is 2026-12-30.

What conditions does trial NCT04903470 study?

This clinical trial studies the following conditions: Constipation by Outlet Obstruction.

What interventions are being tested in trial NCT04903470?

The interventions under investigation include: Bisacodyl (DRUG), Atropin (DRUG).

Who is sponsoring clinical trial NCT04903470?

This trial is sponsored by The California Medical Innovations Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04903470 being conducted?

This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04903470's enrollment target sits among peer trials

130 733rd of 2000 higher than 1,257 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04903470, the US trial registry maintained by the National Library of Medicine. NCT04903470 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.